SUPPLY CHAIN ARTICLES
-
![GettyImages-832049900]( "What Violin Making Can Teach Us About mRNA Therapeutic Quality")
What Violin Making Can Teach Us About mRNA Therapeutic QualityManaging the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.
-
![GettyImages-96831350]( "“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP Principles")
“To Thine Own [mRNA Product] Be True:” Shakespeare's Guide To RNA GMP PrinciplesIn the following article, I offer some of the biggest tips and tricks experts offered during a panel discussion on the challenges of navigating GMP principles in the RNA space today — with a little bit of help from Shakespeare himself.
-
![Man working in vegetable garden-GettyImages-1327986655]( "Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future Directions")
Cultivating A Thriving mRNA Ecosystem: Key Initiatives & Future DirectionsOverall, I felt that the following initiatives/talking points were demonstrative of the types of creativity and symbiosis that we will need much more of in the near and long-term to foster a healthy and fruitful RNA ecosystem.
-
![GettyImages-1335381149]( "Assessing Quality Of mRNA Vaccines: Key Considerations")
Assessing Quality Of mRNA Vaccines: Key ConsiderationsTo address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.
-
![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
-
![protein bio-synthesis GettyImages-1355122387]( "How Can We Move RNA Forward In Our Therapeutics Arsenal?")
How Can We Move RNA Forward In Our Therapeutics Arsenal?RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.
SUPPLY CHAIN VIDEOS
The oligo manufacturing paradigm is facing several different evolutions whether it be the transition to liquid-phase or hybrid synthesis. In this Advancing RNA Live clip, Camp4’s Satya Kuchimanchi explores how these manufacturing advancements are impacting our supply chain needs.
Tune in as Roberta Duncan, VP of the mRNA program at Seqirus; Duke Human Vaccine Institute Associate Director of Upstream and Downstream Process Development Jason Dickens, Ph.D.; and Jin Zhou, Executive Director of Process Development for mRNA and Protein Biologics at Ultragenyx share supply chain and manufacturing capacity constraints in the face of the urgency to address COVID-19. This is an excerpt from the Bioprocess Online Live event - mRNA Manufacturing: Bright Future, Big Challenges.
Advancing RNA Live panelists Tyler Goodwin and April Sena start off our latest discussion on technology innovations in mRNA production by surveying the current manufacturing process for plasmid production, highlighting where they’ve seen advancements and what biotechs need to consider to obtain plasmids of the appropriate quality for mRNA production.
Sanofi’s Sumit Luthra shares several of the analytical and manufacturing innovations/improvements he’s watching and waiting for that will improve our knowledge of LNP composition, structure, function, and quality.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![Cryoport]( "Why Risk Analysis And Lane Qualification Matter")
Risk analysis and lane qualification show supply chains perform consistently, meeting regulatory expectations by demonstrating control, reducing variability, and ensuring reliable delivery.
-
![Developing mRNA Vaccines GettyImages-1307593959]( "Consolidating The Supply Chain For mRNA")
Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
-
![GettyImages-1334686671-cold-chain-cryopreservation-logistics]( "Validate Cryopreservation As A Defined Input, Not A Variable")
Treating cryopreservation as a validated, controlled input improves consistency, quality, and patient outcomes by reducing variability across cell therapy manufacturing, storage, and distribution.
-
![scientist iStock-1166567091]( "mRNA Transfection Reagent Enhances Non-Viral Gene Delivery To Stem Cells")
Researchers demonstrate a delivery mechanism that is a simple and ready-to-use transfection reagent that leads to outstanding transfection efficiencies in known hard-to-transfect stem cells.
-
![iStock-528606286-handshake-partnership-partner-agreement]( "Transitioning From Using RUO To cGMP Chemicals For Clinical Trials")
Learn about the common challenges and risks associated with accelerating your molecule's timeline from lab to clinic, along with important supply chain considerations for emerging biopharma companies.
-
![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
-
![GettyImages-1357908552]( "Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing")
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
